FDA releases policy documents on compounding, including a draft interim guidance and a final guidance

 

 

SILVER SPRING, Md. - The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013. 

 

The policy documents consist of a draft interim guidance, a proposed rule, a final guidance and two revised requests for nominations for the bulk drug substances lists. 

 

“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”

 

The draft interim guidance outlines the FDA’s expectations regarding compliance with current good manufacturing practice requirements for facilities that compound and register with the FDA as outsourcing facilities under section 503B of the Federal Food, Drug and Cosmetic Act. The guidance focuses on cGMP requirements related to sterility assurance of sterile drug products and the general safety of compounded drug products.  

 

The final guidance is for individuals or pharmacies that intend to compound drugs under section 503A, now that the FD&C Act has been amended by the DQSA. The guidance generally restates the provisions of section 503A, describes the FDA’s interim policies with respect to specific provisions that require implementing regulations or other actions and contains a non-exhaustive list of potential enforcement actions against individuals or pharmacies that compound human drug products in violation of the FD&C Act.